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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Howmedica Osteonics Corp.

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  Class 2 Device Recall Stryker Howmedica Osteonics Corp. see related information
Date Initiated by Firm December 20, 2012
Date Posting Updated March 08, 2013
Recall Status1 Terminated 3 on September 30, 2015
Recall Number Z-0919-2013
Recall Event ID 64306
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Code Information Catalog Number: 6266-0-100, Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact
Manufacturer Reason
for Recall
Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
FDA Determined
Cause 2
Process control
Action Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.
Quantity in Commerce 48 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.